After reviewing the 2024 EMA analysis, the European Commission concluded that titanium dioxide (TiO2) remains essential for the quality, safety, and efficacy of many medicines, and that no feasible replacement currently exists. The Commission will therefore maintain its use in medicinal products under Regulation (EU) 2022/63.
The decision acknowledges the pharmaceutical industry’s role in tracking scientific advances and adapting formulations where justified. Companies are encouraged to continue evaluating excipients, including TiO2, when developing new products, ensuring that excipient choices are scientifically sound and regulatory compliant.
Industry feedback to the EU Commission’s Quality Working Party experts states that “Establishing the [permitted daily exposure] will reassure patients that TiO2 use is actively monitored and controlled at safe levels”. For now, titanium dioxide remains a fixture in the EU pharmaceutical landscape, but the conversation about its future use is not over.
TiO2 has long been a staple in medicinal products, valued for its whitening, opacifying, and protective properties. Found in more than 91,000 human and 1,600 veterinary medicines, it helps ensure uniform tablet color, improves product identification, shields active ingredients from light, and maintains visual appeal over a product’s shelf life.
However, the safety of TiO2 has come under scrutiny in recent years. In 2021, the European Food Safety Authority (EFSA) concluded that concerns about genotoxicity could not be ruled out, leading to its ban as a food additive in 2022. While this ban did not extend to medicinal products, the European Commission tasked the European Medicines Agency (EMA) with assessing whether replacement was feasible without compromising quality, safety, efficacy, or availability.
The feasibility challenge
The EMA’s first analysis in September 2021 acknowledged the potential to find alternatives but warned that any substitution would present major technical challenges and disrupt medicine supply chains. The updated 2024 analysis, informed by industry data, confirms those concerns.
The industry and EMA assessed TiO2-free coatings against key performance indicators (KPIs). All tested alternatives fell short in at least one critical area. For example TiO2’s strong opacity helps achieve uniform coverage, even on differently colored tablet cores. Without it, alternatives often require more intense pigments, altering the product’s visual identity, which is an important factor for patient compliance. TiO2 also offers superior light protection. Alternatives often require additional protective packaging to prevent degradation of light-sensitive medicines.
Separately, in March 2025 the EMA reviewed new safety data submitted by an industry consortium. Although not a full re-evaluation, the assessment – supported by the European Chemicals Agency (ECHA) and EFSA – found that any carcinogenic risk from titanium dioxide in medicines is negligible, reflecting both the pharmaceutical-grade purity and the small quantities used.
TiO2 is deeply embedded in pharmaceutical development pipelines, used from the earliest formulation stages through clinical trials. The EMA estimates that even if a suitable alternative were found, reformulating a company’s full product portfolio would take 7-12 years due to staggered reformulation schedules, manufacturing adjustments, and regulatory approvals.
Newsletters
Receive the latest pharmaceutical news, personalities, education, and career development – weekly to your inbox.
